A Study for Treatment of Paroxysmal Atrial Fibrillation (PAF) by Pulsed Field Ablation (PFA) System With Irreversible Electroporation (IRE) (inspIRE)
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|ClinicalTrials.gov Identifier: NCT04524364|
Recruitment Status : Recruiting
First Posted : August 24, 2020
Last Update Posted : December 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Pulsed Field Ablation (PFA) Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||550 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pulsed Field Ablation (PFA) System for the Treatment of Paroxysmal Atrial Fibrillation (PAF) by Irreversible Electroporation (IRE)|
|Actual Study Start Date :||August 23, 2020|
|Estimated Primary Completion Date :||August 30, 2022|
|Estimated Study Completion Date :||August 30, 2022|
Participants with Paroxysmal Atrial Fibrillation (PAF)
Participants with PAF and who are candidates for catheter ablation will be enrolled.
Device: Pulsed Field Ablation (PFA) Therapy
Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).
- Number of Participants with of Primary Adverse Events (PAEs) [ Time Frame: Within one week (7 days) post-procedure ]Participants with incidence of Primary Adverse Events (PAEs) (within seven (7) days of the initial mapping and ablation procedure) will be reported. PAEs include the adverse events like Atrio-esophageal fistula, cardiac tamponade/perforation, device or procedure related death, major vascular access complication/bleeding, myocardial infarction and pericarditis, phrenic nerve paralysis (permanent), pulmonary vein stenosis, stroke/CVA, thromboembolism, transient Ischemic Attack (TIA)
- Rate of Freedom from Documented (Symptomatic and Asymptomatic) Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL] Greater than Equal to (>=)30 Seconds Within 91-365 days post Index Procedure [ Time Frame: 91-365 Days ]Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
- Number of Participants who Achieved Acute Procedural Success [ Time Frame: 91-365 Days ]Acute procedural success defined as confirmation of entrance block in all clinically relevant targeted PVs after adenosine/ isoproterenol challenge.
- Rate of Freedom from Documented Symptomatic Re-Occurrence Atrial Arrhythmia (Atrial Fibrillation [AF], Atrial Tachycardia [AT], or Atrial Flutter [AFL]) >=30 Seconds Within 91-365 days post Index Procedure [ Time Frame: 91-365 Days ]Atrial arrhythmia recurrence events will be recorded and included as a study endpoint after a 90-day blanking period; recurrence during the blanking will not be considered treatment failure. In addition, re-ablation will not be recommended during the blanking period.
- Change from Baseline in Atrial Fibrillation Effect on Quality of Life (AFEQT) Total Score [ Time Frame: Baseline, Month 3, 6 and 12 ]An overall AFEQT score ranges from 0 to 100. A score of 0 corresponds to complete disability (or responding "extremely" limited, difficult or bothersome to all questions answered), while a score of 100 corresponds to no disability (or responding "not at all" limited, difficult or bothersome to all questions answered). Therefore, a positive change in score corresponds to improvement in AF symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524364
|Contact: Macours Nathalie||+32 ext 479 97 05 email@example.com|
|Aalst, Belgium, 9300|
|Southlake Regional Health Centre||Not yet recruiting|
|Newmarket, Canada, ON L3Y 2P9|
|University Hospital Center Split||Not yet recruiting|
|Split, Croatia, 21000|
|Nemocnice na Homolce||Recruiting|
|Prague, Czechia, 150 30 District 5|
|Ospedale Generale Regionale "F. Miulli"||Not yet recruiting|
|Acquaviva Delle Fonti (Bari), Italy, 70021|
|Vilnius University Hospital||Recruiting|
|Vilnius, Lithuania, 8661|